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510(k) K163677

Ortho System by 3Shape A/S — Product Code PNN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2017
Date Received
December 27, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthodontic Software
Device Class
Class II
Regulation Number
872.5470
Review Panel
DE
Submission Type

The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions. It may include orthodontic output devices used for the treatment of orthodontics. The device is intended for prescription use only.

Other clearances by 3Shape A/S

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  • K191911 — 3Shape Splint Design (November 27, 2019)
  • K180941 — Ortho System (October 17, 2018)
  • K171634 — Ortho System (January 17, 2018)
  • K161884 — Ortho System (April 19, 2017)
  • K151455 — 3Shape Abutment Designer Software (September 6, 2016)
  • K152086 — 3Shape Ortho System (April 28, 2016)

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